NIDA-CTN-0055

This is an open-label, randomized, pilot trial of XR-NTX vs. treatment as usual (TAU) for treatment of opioid and alcohol use disorders in HIV-infected patients, whose goal is to determine the acceptability and feasibility of XR-NTX in HIV practice and inform development of a multi-site comparative effectiveness trial of XR-NTX vs. TAU in HIV clinics. During the study start-up period, we will conduct a survey of HIV provider attitudes toward opioid antagonist therapy at 15 high-volume HIV clinics to assess willingness to prescribe antagonist therapy and inform the site selection process (Aim 1). During pilot study implementation, we will survey HIV-infected patients regarding attitudes toward opioid antagonist therapy (Aim 2), track rate of participant recruitment (Aim 3), and randomize those who have untreated opioid and/or alcohol use disorders to receive XR-NTX vs. TAU (Aim 4). Participants will attend study visits every 4 weeks for 16 weeks. Treatment initiation will be assessed at 4 weeks and retention at 16 weeks (4 XR-NTX injections). Randomization will continue until a maximum of 50 participants or 12 months are reached. Pilot study duration will be a maximum of 17 months (maximum 12 months recruitment + 5 months study participation for those enrolled at the end of the recruitment period). We will assess feasibility of a multi-site trial of XR-NTX vs. TAU by addressing four pilot study specific aims.